Regulatory Compliance in Clinical Trials
( 25 Modules )

Module #1
Introduction to Regulatory Compliance in Clinical Trials
Overview of the importance of regulatory compliance in clinical trials, key regulations, and guidelines

Module #2
ICH-GCP and Regulatory Framework
In-depth review of ICH-GCP guidelines, FDA regulations, and EU directives governing clinical trials

Module #3
Clinical Trial Protocol Development
Best practices for developing a compliant clinical trial protocol, including content, format, and review

Module #4
Investigational New Drug (IND) Applications
Understanding the IND application process, including preparation, submission, and maintenance

Module #5
Institutional Review Board (IRB) Roles and Responsibilities
Overview of IRB roles, responsibilities, and regulations, including IRB review and approval

Module #6
Informed Consent and Human Subject Protection
Key principles and regulations governing informed consent, including process, documentation, and ethics

Module #7
Clinical Trial Registration and Results Disclosure
Understanding clinical trial registration, results disclosure, and transparency requirements

Module #8
Good Clinical Practice (GCP) Inspections and Audits
Preparation for and management of GCP inspections and audits, including FDA and EU regulations

Module #9
Clinical Trial Data Management and Quality Control
Best practices for clinical trial data management, including data quality, validation, and cleaning

Module #10
Adverse Event Reporting and Pharmacovigilance
Regulatory requirements for adverse event reporting, including expedited reporting, and pharmacovigilance

Module #11
Clinical Trial Monitoring and Oversight
Roles and responsibilities of clinical trial monitors, including on-site and remote monitoring

Module #12
Regulatory Compliance in Different Regions
Overview of regulatory compliance requirements in the US, EU, Canada, and Asia-Pacific regions

Module #13
Risk Management in Clinical Trials
Identifying and mitigating risks in clinical trials, including risk assessment and risk-benefit analysis

Module #14
Quality Assurance and Quality Control in Clinical Trials
Implementing quality assurance and quality control processes in clinical trials, including SOPs and quality metrics

Module #15
Regulatory Compliance in Electronic Data Capture (EDC) and eSource
Best practices for regulatory compliance in EDC and eSource systems, including data integrity and validation

Module #16
Clinical Trial Audit and Inspection Readiness
Preparation and management of clinical trial audits and inspections, including audit trail and documentation

Module #17
Regulatory Compliance in Medical Devices and Diagnostics
Overview of regulatory compliance requirements for medical devices and diagnostics in clinical trials

Module #18
Collaboration with Regulatory Authorities
Effective communication and collaboration with regulatory authorities, including FDA and EMA interactions

Module #19
Regulatory Compliance in Pediatric and Orphan Drug Trials
Unique regulatory considerations for pediatric and orphan drug trials, including ethical and logistical challenges

Module #20
Regulatory Compliance in Oncology Trials
Specialized regulatory considerations for oncology trials, including compassionate use and expanded access

Module #21
Regulatory Compliance in Gene and Cell Therapy Trials
Emerging regulatory considerations for gene and cell therapy trials, including FDA and EU guidelines

Module #22
Regulatory Compliance in Digital Health and Mobile Health Trials
Unique regulatory considerations for digital health and mobile health trials, including data privacy and security

Module #23
Regulatory Compliance in Artificial Intelligence and Machine Learning Trials
Emerging regulatory considerations for AI and ML trials, including algorithm validation and bias mitigation

Module #24
Regulatory Compliance in Rare Disease Trials
Specialized regulatory considerations for rare disease trials, including orphan drug designation and priority review

Module #25
Course Wrap-Up & Conclusion
Planning next steps in Regulatory Compliance in Clinical Trials career

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Regulatory Compliance in Clinical Trials ( 25 Modules )

Regulatory Compliance in Clinical Trials
( 25 Modules )